Reducing Risk of Diabetic Ketoacidosis in Type 1 Diabetes and Kidney Disease Using Continuous Ketone Monitoring

Starting soon · Phase 2

Conditions studied: Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM), Chronic Kidney Disease

In brief

The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1 diabetes (T1D) and mild to moderate chronic kidney disease (CKD). The main objectives of this study are to: 1. Evaluate how ketone metrics differ between participants with mild to moderate chronic kidney disease and those with normal renal function in three time periods. 2. Identify potentially modifiable ketosis risk factors. 3. Use continuous glucose monitoring (CGM) and continuous ketone monitoring (CKM) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors. 4. Gather information on how participants and clinicians like and use the CGM/CKM reports. Participants will be asked to: * Meet with study investigators to determine if they are eligible * Sign written informed consent * Take a pregnancy test, if applicable * Have blood taken to assess kidney function and hemoglobin A1c * Take the study medication, following the study team instructions * Wear the study provided sensor throughout participation. * Complete 5 in person visits, and 11 phone check ins over a nine-month period * Provide feedback on the usefulness of CGM/CKM reports

Key facts

Study ID: NCT07325201
Run by: HealthPartners Institute
People needed: 80
Starts: 2026-06-01
Expected to finish: 2028-08-01
Last updated by the study team: 2026-02-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Males and females; Ages 18-75.
Diagnosis of type 1 diabetes, based on a clinical diagnosis with onset at least 3 months prior to screening.
Using an automated insulin delivery system (AID) or multiple daily injections (MDI), (defined by use of rapid analogue with meals and approved long-acting analogue (e.g. detemir or glargine)).
Most recent eGFR ≥30 (and within prior 12 months).
HbA1c <10%. 8) Have had ≥1 primary or specialty ambulatory visit(s) in the past year in the HealthPartners care system.
Have never been prescribed SGLT2i medications.
Must be willing and able to wear a CGM/CKM device and willing to follow the study protocol.
Must be able to read and speak English.
Use of adequate contraception for the duration of the study be the women of childbearing potential.
Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access).

You may not qualify if…

Pregnancy, lactation, planning to become pregnant or unwillingness to be on contraception during the trial.
Any form of diabetes other than T1D.
Any history of use of sodium-glucose cotransporter inhibitors and use of other non-insulin glucose lowering medication within the last 6 months.
Chronic systemic corticosteroids (>4 consecutive weeks) within 6 months before screening or planned use during the study period.
History of diabetic ketoacidosis within 3 months of screening or 2 or more episodes of DKA within the last year.
History of multiple (≥ 3 infections) genital mycotic infections within 6 months of screening.
Hypotension at screening as defined as, systolic blood pressure < 90 and diastolic blood pressure < 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations).
History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening.
Recent myocardial infarction, stroke, hospitalization for unstable angina or heart failure within 3 months prior to screening.
New York Heart Association Class IV heart failure.
CKD-EPI estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2.
Impairment of systems and organs that may increase their risk of participating in the intervention study or compromise the results (for example: end stage kidney disease, active liver dysfunction, gastroparesis, anemia, organ transplant).
Active Hepatitis B or C, or tuberculosis.
Abnormal liver function at screening defined as any of the following: aspartate aminotransferase (AST) >2X upper limit of the normal reference range (ULN), ALT >2X ULN, serum total bilirubin (TB) >1.5X ULN.
History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status, in the opinion of the investigator, including, but not limited to patients who have undergone organ or bone marrow transplantation. HIV positive patients who are on stable immunosuppressive therapy and have undetectable viral load may be eligible for inclusion in the study, subject to the investigator's discretion.
Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and/or known diagnosis of cirrhosis.
Cancer treatment (excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer) within one year of screening.
History of kidney transplant.
CKD from a known cause other than T1D.
A diagnosed eating disorder.
BMI <22.
Adherence to a very low CHO or ketogenic diet.
A foot amputation.
Non-healing wounds of extremities.
Inability to perform the study follow up/ unwilling to wear the investigational device.

Where it is running

International Diabetes Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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